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NCT00052039 Clinical Trial

A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone

Pulmonary Fibrosis Clinical Trial

Official title:
A Randomized, Double-Blind, Three-Arm, Phase IIIb Study Comparing the Safety and Efficacy of Interferon Gamma-1b Alone, IFN-Gamma 1b With Azathioprine, and Azathioprine Alone in Patients With Idiopathic Pulmonary Fibrosis Receiving Prednisone

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00052039
Other study ID # GIPF-003
Secondary ID
Status Terminated
Phase Phase 3
First received January 21, 2003
Last updated November 2, 2007
Start date April 2002
Est. completion date June 2002

Study information
Verified date November 2007
Source InterMune
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210 patients.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date June 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• interferon-gamma 1b
This study was terminated prior to enrollment.
• azathioprine
This study was terminated prior to enrollment.

Locations
Country Name City State
Italy Ospedale S. Luigi Gonzaga - Regione Torino Orbassano

Sponsors (1)
Lead Sponsor Collaborator
InterMune

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary This study was terminated prior to enrollment. This study was terminated prior to enrollment.
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